JOB RESPONSIBILITIES
Manage safety queries and other significant safety information locally, inclusive of crisis management.
Prepare, maintain and implement the necessary SOPs that meet the requirements of the regulations with respect to drug safety.
Conduct local literature search and ensure any other safety data deemed fit for inclusion in the PSUR/PBRER or signal management process.
Review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
Continual risk assessment of local PV operations, including early notification of any risks.
Responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations and registration renewals.
Manage Import License and associated Product List in timely manner to ensure continuous supply of stock.
To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
JOB REQUIREMENTS
Degree in Pharmacy (with Pharmacist License).
Minimum 5 years or more in PV and RA role in pharmaceutical company.
Able to work independently and with others, positive attitude, willingness to embrace new skills.
Fluency in English and Bahasa Malaysia (written and spoken).
IT: Microsoft Office (PowerPoint, Excel, Word).
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